Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA) National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Funding Opportunity Title	Women & Sex/Gender Differences in Drug and Alcohol Abuse/Dependence (R03)
Activity Code	R03 Small Grant Program
Announcement Type	Reissue of PA-11-049
Related Notices	January 29, 2018 - This PA has been reissued as PA-18-601. May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062. April 7, 2017 - Notice of Change in the Expiration Date for PA-14-037. See Notice NOT-DA-17-015. January 05, 2017 - Notice to Extend PA-14-037. See Notice NOT-DA-16-045. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) October 20, 2014 - See Notice NOT-DA-14-051. Notice of Correction to Application Package for PA-14-037 "Women & Sex/Gender Differences in Drug and Alcohol Abuse/Dependence (R03)" June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	PA-14-037
Companion Funding Opportunity	PA-14-038, R01 Research Project Grant PA-14-036, R21 Exploratory/Developmental Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279, 93.273
Funding Opportunity Purpose	The purpose of this Funding Opportunity Announcement (FOA) is to advance research on male-females differences in drug and alcohol abuse and addiction and on factors specific to women. Both human and animal model studies are sought.

Posted Date	December 12, 2013
Open Date (Earliest Submission Date)	January 16, 2014
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Standard AIDS dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	New Date January 8, 2018 per issuance of NOT-DA-17-015. (Original Expiration Date: May 8, 2017)
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This R03 Small Grant mechanism will support small research projects that can be carried out in a short period of time with limited resources. The common characteristic of the small grant is the provision of limited funding for a short period of time. Examples of the types of projects supported under the R03 include the following: pilot or feasibility studies; small, self-contained research projects; secondary analysis of existing data for the purpose of detecting outcomes separately for males and females; and research methodology development or new research technology to enhance research on females or to detect male-female differences. No preliminary data are required but may be included if available.

Research Objectives
On September 27, 2010, the NIH Office of Research on Women’s Health released the strategic plan, Moving into the Future with New Dimensions and Strategies: A Vision for 2020 for Women’s Health Research (http://orwh.od.nih.gov ). The plan sets forth a women’s health research agenda for NIH for the next decade and includes six goals. The present funding opportunity announcement embraces those goals as applied to drug and alcohol abuse and contains special emphasis on the first goal which is to increase sex differences research in basic science studies. That goal, along with its nine objectives, is consistent with recommendations in the 2001 Institute of Medicine report, Exploring the Biological Contributions to Human Health: Does Sex Matter? (http://lab.nap.edu/openbook.php?isbn=0309072816&page=1). It is also consistent with recommendations in the September 23, 2010 IOM report, Women’s Health Research: Progress, Pitfalls, and Promise (http://www.iom.edu/Reports/2010/Womens-Health-Research-Progress-Pitfalls-and-Promise.aspx). Further, it is consistent with the need to increase sex differences research in the neurosciences as identified in the March 5, 2010 IOM meeting, Sex Differences: Implications for Translational Neuroscience Research (http://www.iom.edu/Activities/Research/NeuroForum/2010-MAR-08/Agenda%20Sex%20Difference%20Translational%20Neuroscience%20Research.aspx) and its ensuing publication, http://www.iom.edu/Reports/2010/Sex-Differences-and-Implications-for-Translational-Neuroscience-Research.aspx. More recently, the need for sex-specific reporting of research findings was emphasized in the 2012 IOM report, Sex-Specific Reporting of Scientific Research - Workshop Summary (http://www.iom.edu/Reports/2012/Sex-Specific-Reporting-of-Scientific-Research.aspx ).

Historically, in drug and alcohol abuse research, as in other fields of public health research, participants were largely male. Research findings that have emerged for over the past two decades, however, have clearly established the importance of studying factors specific to women and differences between males and females in all areas of drug and alcohol abuse research. From basic studies of molecular genetics and neurotransmitter systems to studies of epidemiology, etiology, consequences and prevention/treatment interventions and services, the scientific and clinical importance of analyzing data separately for males and females is becoming more and more evident. Not only are growing numbers of studies reporting outcomes that are specifi c to either males or females, outcomes that are opposite in males and females also are often found. These findings reveal that failure to analyze data separately for males and females can lead to incorrect conclusions regarding males or females or both.

Accumulating epidemiological and clinical research indicates that the predictors of drug and alcohol use, abuse, and dependence often differ in males and females. Among them are psychiatric co-morbidities, physical and sexual abuse, trauma, prenatal drug exposure and family dysfunction. Some predictors are gender-sensitive; that is, they are stronger for either males or females. Others are gender-specific; that is, they apply only to males or to females. And others are opposite in males and females. The implications of these types of gender-based differences in risk factors remain largely unexplored; however, they raise the possibility that interventions that target gender-based risk factors and are guided by male-female differences in social, cognitive and emotional development could improve outcomes for both males and females.

Animal and human laboratory research has shown that males and females often differ in their behavioral and biological responses to drugs. Animal studies, for example, have found male-female differences in the motor-activating effects of stimulants, speed of acquisition of drug self-administration, the amount of drug self-administered, the percentage of subjects that acquire self-administration, escalation of drug self-administration, motivation for self-administration, and the tendency to relapse following drug cessation. Further, factors that affect those outcomes often do so differently in males and females. Human and animal pharmacokinetic studies often report male and female differences, as do studies of adverse effects of abused drugs. Both human and animal studies have established that the menstrual/estrous cycle is a determinant of drug action, both pharmacokinetic and behavioral. Growing numbers of brain-imagining studies are reporting male-female differences. Despite the important progress made in laboratory sex/gender-based research, it is in an early stage and most researchers fail to analyze their data by sex/gender.

Numerous male-female differences in cigarette smoking and nicotine dependence have been reported, including differences in use patterns and dependence susceptibility, cessation rates and relapse rates, effectiveness of nicotine replacement therapies and other pharmacotherapies, the role of non-nicotine factors, nicotine metabolism, and pharmacogenetics. Indeed, research on male-female differences in nicotine dependence has exceeded that of other drugs of abuse and thus may serve to guide research on other abused drugs. Nevertheless, many gaps remain in our understanding of male-female differences in the nature of nicotine addiction and its prevention and treatment, including factors specific to females such as the menstrual cycle, pregnancy, menopause status, weight control concerns and other barriers to cessation.

Male-female differences have been identified in various aspects of drug abuse treatment and services research including barriers to treatment, treatment entry characteristics, treatment and services needs, and predictors of treatment engagement, retention, and outcomes. Research often finds that treatments are not equally efficacious in males and females. These male-female differences in treatment research, along with research showing male-female differences in the determinants and predictors of drug abuse, raise the possibility that even when treatments are shown to be equally effective for males and females, outcomes could be improved by the addition of gender-based approaches that are informed by this growing body of research.

According to 2010 HIV/AIDS surveillance data from the Centers for Disease Control and Prevention

among persons living in the U.S with a diagnosis of HIV infection at the end of 2010, injection drug use (IDU) was associated with a greater percentage of cases among women than among men (http://www.cdc.gov/hiv/surveillance/resources/reports/2010report/pdf/2010_HIV_Surveillance_Report_vol_22.pdf). The HIV/AIDS disease process has been found to differ between males and females; for example, an HIV-infected woman with half the amount of virus circulating in the bloodstream as an infected man will progress to a diagnosis of AIDS in about the same time as the man despite comparable immune parameters (e.g., CD4 counts). Additionally, there is evidence that neurocognitive measures may differ between HIV+ drug using males and females and that they may be differentially impacted by HIV risk reduction interventions. Although drug abuse plays a greater role in HIV among women than men, major gaps remain in knowledge regarding male-female differences in the role of drug abuse in HIV/AIDS, including the unique needs of women and how to address them in prevention and treatment efforts.

The extant literature on male-female differences in drug abuse strongly suggests that males and females are likely to differ in many aspects of drug abuse yet to be explored and that in the long run, identifying and understanding such differences can improve our understanding of the nature and etiology of drug abuse and have implications for tailoring prevention and treatment interventions to maximize outcomes for both males and females. Although progress has been made in our knowledge of male-female differences in drug abuse and issues unique to women, many gaps remain. Often studies fail to include sex/gender analyses, and only a very small proportion of animal studies includes female subjects thus providing no opportunity to analyze data for sex differences and therefore running the risk that knowledge gained from animal models of drug abuse is limited to males. Thus, in all areas of drug abuse, research is needed that examines male-female differences and factors specific to females.

Terminology: In scientific literature on differences between males and females, the terms sex and gender are sometimes used interchangeably. However, they have very different meaning as described in the 2001 IOM report, Exploring the Biological Contributions to Human Health: Does Sex Matter? (http://lab.nap.edu/openbook.php?isbn=0309072816&page=1, page 1), wherein sex is defined as the classification of living things, generally as male or female according to their reproductive organs and functions assigned by their chromosomal complement, and gender as a person s self-representation as male or female, or how that person is responded to by social institutions on the basis of the individuals gender presentation. Gender is shaped by environment and experience. Thus, sex is a biological construct whereas gender is a psychosocial construct. This distinction notwithstanding, epigenetic research reveals that biological factors often unfold in ways that are influenced by the environment, and thus can obviate this distinction between sex and gender. Because it is often not known a priori whether a male-female difference is sex-based or gender-based or both, in this funding opportunity announcement sex/gender difference will sometimes be used generically to refer to male-female differences especially when the biological and social origins of the differences are unknown or likely involve both. Of course, the search for those origins is a major focus of this announcement. In non-human animal research, however, the term sex difference is the preferred term. Additionally, researchers are urged to recognize that a sex/gender difference is often a proxy for an unidentified independent variable(s) and therefore can serve as a research tool. Thus, finding a sex/gender difference typically should be regarded as a first step in a search for such variables as their identification will shed light on the phenomenon under study.

Areas of research interest include, but are not limited to, the following:

I. ETIOLOGY AND MECHANISMS OF DRUG ABUSE: In both animal and human research, study sex/gender differences in the basic behavioral and biological mechanisms underlying drug abuse and dependence across the lifespan; and conduct laboratory, epidemiological, and clinical studies of male-female differences in the determinants of initiation, progression, and maintenance of drug use and dependence. Examples include:

• Studies of the genetic and epigenetic basis of sex/gender differences in drug abuse and dependence using a variety of methodologies, including statistical or epidemiological studies to ascertain heritability; identification of genetic variants through linkage, linkage disequilibrium, or association studies; studies of candidate genes using knockout or over-expression technologies in model organisms; gene expression studies.
• Studies of sex/gender differences in gene-environment interactions on drug abuse vulnerability.
• Sex differences in animal models of interactions between individual risk factors (e.g., impulsivity, stress reactivity) and environmental factors (e.g., impoverished versus enriched environments).
• Animal models of sex differences in differential hedonic responsivity to appetitive and aversive stimuli as related to drug abuse vulnerability.
• Sex/gender differences in risk and protective factors for drug initiation, acquisition, escalation, dependence, and relapse and the role of circulating sex steroids.
• Animal models of menopause.
• Study of pre-mating parental factors associated with drug abuse in male and female offspring, e.g., pre-mating exposure to drugs of abuse, stress, poor nutrition, endocrine disruptors, environmental toxins, etc.
• Sex/gender differences in the transgenerational transmission of drug use in both animal models and family studies.
• Sex/gender differences in the role of psychiatric comorbidities in the development and maintenance of drug abuse in both animal models and human studies.
• Sex differences in the role of organizational effects of sex steroids in the development of drug abuse, including their role in the ontogeny of the brain reward system.
• Sex differences in the effects of chromosomal complement versus sex steroid effects on drug abuse.
• Sex differences in neurotransmitter systems, brain reward circuitry and gene expression associated with drug abuse including the role of sex steroids.
• Sex/gender differences in the biological substrates of drug abuse, including molecular, cellular, neurochemical, neuromodulatory, neuroendocrine.
• Sex/gender differences in the pharmacokinetics and pharmacodynamics of abused drugs.
• Sex/gender differences in the role psychosocial and cognitive factors in modulating drug effects and drug use.
• Preclinical models of social factors and impoverished versus enriched environments.
• Sex/gender differences in the role of current or prior stress, trauma, violence, victimization and bullying in the development and maintenance of drug abuse and dependence.
• Sex/gender difference in modulation of drug abuse vulnerability by interactions between the HPA an HPG axes and neurotransmitter systems.
• Laboratory studies of sex/gender differences in the role of tolerance, sensitization, habituation, behavioral alternatives, impulsivity, delay discounting, stress, learning, memory, and cognition in the development and maintenance of drug abuse.
• Field studies of sex/gender differences in the antecedents and pathways to drug abuse and dependence, including study of psychosocial and environmental risk and protective factors associated with initiation, progression, and maintenance of drug use.
• Sex/gender differences in the roles played by the timing of puberty, the transition to puberty (e.g., onset of menarche), adolescent physique characteristics, and body image distortion in the onset and progression of drug abuse.
• Sex/gender differences in studies of cumulative accrual of multiple risks throughout development.
• Sex/gender differences in opportunity to use drugs, access to drugs, patterns of drugs of use and abuse, and factors affecting these differences.

II. CONSEQUENCES AND IMPACT: Laboratory (both human and animal), field, and clinical research aimed at (a) identifying sex/gender differences across the lifespan in the consequences of drug use, abuse, and addiction following acute use, chronic use, as well as residual effects following prolonged abstinence, or (b) examining drug-related consequences that are unique to females. Examples include:

• Sex/gender differences in the effects of abused drugs on various biological systems including brain structure and function (e.g., effects on brain reward and stress pathways and effects on neurocognitive circuitry) and effects on endocrine, immune, cardiovascular, pulmonary and skeletal systems.
• Sex/gender differences in the acquisition and transmission of co-occurring infections (e.g., HIV, HCV, TB, and STDs) among drug users, and its clinical course and consequences.
• Laboratory-based studies of sex/gender differences in the effects of abused drugs on learning, memory and cognition, and the response to stress.
• The effects of drugs of abuse on reproductive behaviors and maternal and paternal functioning (e.g., parental care, attachment, abuse and neglect) and differential impact on male and female offspring.
• Sex/gender differences in the effect of drug use on the development and maintenance of social behavior, e.g., play, cooperation, empathy, conflict, hostility, violence and aggression.
• Sex/gender differences in the precipitation and/or exacerbation of psychiatric disorders following drug use/abuse.
• The effects of drugs of abuse on the menstrual/estrous cycle and on menopause.
• The impact of drug abuse during pregnancy on the health, both physiologically and psychologically, of the mother and her fetus/infant.
• Sex/gender differences in offspring prenatally exposed to abused drugs either via in utero exposure or parental drug use (maternal, paternal or both) prior to conception; interactions with postnatal factors.
• Sex/gender differences in the transgenerational impact of drug use, including animal model investigations of the biological mechanisms.
• Sex/gender differences in the effect of drugs on attainment of age-appropriate developmental levels, both physiologically and psychologically.
• Sex/gender differences in the short- and long-term effects of exposure to drug-abusing family members (parents, siblings and partners) and peers.
• Sex/gender differences in the socioeconomic and legal consequences of drug abuse, including the effects on education, employment, poverty, homelessness, gang activities, drug trafficking, and family functioning; (e.g., disruption, dislocation, violence, divorce and child custody).
• Sex/gender differences in pain and analgesia, the underlying mechanisms, and in efficacy of both pharmacological and non-pharmacological pain treatments.

III. PREVENTION AND PREVENTION SERVICES: Design, develop and test the efficacy/effectiveness of sex/gender-based prevention strategies that are informed by sex/gender-based theories (e.g., psychosocial, biological, developmental) and empirical findings on the risk and protective factors related to drug abuse initiation, progression, transition, and maintenance. Examples include:

• Assess the differential effectiveness of drug abuse prevention interventions in males and females and the intervention characteristics and/or components that account for male-female differences in outcomes.
• Identify gender differences in the moderators and mediators of prevention outcomes.
• Develop developmentally-appropriate gender-based universal, selective and indicated prevention strategies that are guided by etiologic research findings on sex/gender differences in risk and protective factors and by sex/gender differences in psychosocial and cognitive development.
• In family-based prevention interventions, examine the effect of gender congruence between the participating parent and child on prevention outcomes.
• Develop gender-based screening and assessment tools aimed at identifying both risk and protective factors for use at the individual, family and community levels and in health care settings.
• Develop interventions that consider the role of childhood and adulthood violence and victimization in differentially perpetuating drug abuse in males and females with attention to environmental, psychosocial and cultural factors that differentially keep them in the cycle of violence.
• Conduct prevention studies on the role of effective gender-specific communication in media and interpersonal interventions.
• Assess the effectiveness of gender-based prevention services and the factors that affect their availability, adoption, adaptation, implementation, sustainability, cost benefit, and cost effectiveness.
• Assess differential long-term effects of exposure to substance abuse prevention programs in males and females.

IV. TREATMENT AND TREATMENT SERVICES: Develop and test the efficacy/effectiveness of sex/gender-based treatment approaches (both behavioral and pharmacologic) that are informed by relevant sex/gender-based theories (e.g., biological, psychosocial, developmental) as well as empirical findings on gender differences in drug abuse including, e.g., sex/gender differences in risk factors, psychopathology and factors affecting treatment entry, completion, and outcomes. Examine gender-based issues related to the effective and efficient delivery of drug abuse treatment and treatment services. Examples include:

• Assess the differential effectiveness of current drug abuse treatments, (both behavioral and pharmacologic) in males and females.
• Develop gender-based behavioral therapies and pharmacotherapies, alone and in combination in a variety of treatment settings, including traditional community-based drug treatment programs, criminal and juvenile justice settings, and primary care settings such as office-based practices and primary care clinics.
• Develop alternative or complementary therapies for drug abusers (e.g., biofeedback, acupuncture, herbal therapies) and compare their effectiveness in males and females.
• Develop gender-based relapse prevention strategies based upon gender differences in relapse predictors.
• Examine sex/gender differences in the role of psychiatric disorders comorbidities on drug abuse treatment outcomes.
• Examine sex/gender differences in the use of biobehavioral assays (e.g., brain-imaging technology, stress reactivity, HPA indices) in predicting treatment outcomes.
• Examine sex/gender differences in genetic studies of treatment outcomes.
• Examine sex/gender differences in the impact of psychological trauma (e.g., childhood physical and sexual abuse, intimate partner violence) on drug abuse treatment process variables and outcomes.
• Develop and examine gender-based treatment and services approaches for individuals having experienced psychological trauma and for individuals with co-occurring drug abuse and mental disorders (e.g., depression, eating disorders, PTSD), STIs, HIV, and/or Hepatitis (B and C).
• Develop and test family-oriented treatment approaches that consider gender-based factors with respect to both parents and children.
• Develop and test treatment approaches aimed at the role of partner drug use.
• Identify effective pharmacotherapy use practices for females of all ages including adolescence and pre-, peri- and postmenopausal women with consideration for issues such as developmental status, use of contraceptives, use of hormone therapy, and ovarian hormone status.
• Determine best treatment practices for the use of pharmacotherapy in the treatment of pregnant women and mothers who breastfeed.
• Develop interventions that recognize the challenges of low-income, under-educated parenting women.
• Determine best relapse prevention practices for post-partum women who stopped using substances during pregnancy.
• Identify gender-based factors affecting drug abuse treatment seeking, treatment access, treatment readiness, treatment entry, treatment retention and completion, treatment compliance, and treatment outcomes including abstinence, relapse, and long-term sustained behavioral change. Use these gender-based factors to develop gender-based treatment and services strategies.
• Identify gender-specific needs for and use of services ancillary to drug abuse treatment (e.g., childcare, transportation, housing, skills training, assertiveness training, and vocational training) and their differential impact on males and females with respect to access, utilization, retention, completion, outcomes and cost-benefit.
• Identify organizational, management, and treatment financing practices that impede or facilitate access, utilization, retention and outcomes for female clients and assess the structure and role of organization in the development of linkages to other relevant treatment services (e.g., medical services, prenatal clinics, psychiatric services) to ensure retention and continuity of care for females, including pregnant and postpartum females.
• Develop or enhance and evaluate gender-based instruments for matching drug-abusing clients to appropriate services, and for identifying, diagnosing and assessing substance abusers in a variety of treatment settings especially primary care settings.
• Sex/gender-based research to determine the most effective time to initiate behavioral and pharmacological treatment taking into consideration menstrual cycle phase and seasonal variations.

V. HIV/AIDS and RELATED INFECTIOUS DISEASES: Develop and evaluate sex/gender-based interventions directed at preventing and treating HIV/AIDS and related infectious diseases among drug using populations and those at risk for drug use at every age level.

• Examine sex/gender differences in the viral, immunologic, genetic, and drug use factors that may influence susceptibility, recovery and persistence, and progression of viral diseases associated with drug use.
• Examine sex/gender differences in neurocognitive effects of drug use in HIV/AIDS individuals.
• Develop and test gender-based interventions to reduce gender-based risks of HIV exposure and transmission among drug using populations. Especially desirable are interventions that also address STIs, HCV, HBV, and/or risks for TB and other infectious diseases that often co-occur with HIV or affect acquisition and treatment course.
• Examine sex/gender differences in associations among history of violence and victimization, HIV risk behaviors, and drug abuse.
• Examine sex/gender differences in factors influencing long-term therapeutic effectiveness of HIV treatment regimens, treated disease progression, development of viral resistance, and medical outcomes.
• Examine sex/gender differences in the interactions/effects of antiretrovirals when used in combination with drugs of abuse and/or medication to treat drug abuse and/or medication to treat co-occurring disorders.
• Develop gender-based strategies (including behavioral, cognitive, social/ecological, provider-based, setting-based) to improve access, referral, utilization and adherence to HIV/AIDS medication regimens for drug-abusing populations both in and out of treatment.
• Examine male-female differences in the behavioral dynamics and drug use-related processes associated with the acquisition and transmission of HIV and other infectious diseases (e.g., TB, HCV, HBV, STIs), including factors that influence transitions from non-injection to injection drug use and their implications for the development of prevention interventions.
• Develop gender-based intervention strategies to improve clinical care for HIV, prevention of HIV transmission, and prevention of HIV-associated infectious diseases (e.g., TB, HCV, HBV, STIs).
• Develop gender-based strategies for the clinical management of individuals on multiple therapies for HIV and other infectious disease including co-morbid psychiatric disorders.
• Develop gender-based intervention strategies aimed at the individual-level (provider and/or patient), intimate partner dyads, families, as well as systemic and structural factors, including case management systems and organized systems of care.
• Develop valid, reliable screening instruments for assessing HIV/STD risk-of-exposure and transmission based upon gender- and age-group-specific, empirically-based normative data.
• Develop and test gender-based methods for maintaining behavior change and preventing relapse to drug using and/or sexual risk behaviors associated with HIV exposure and transmission.
• Develop and test gender-based methods for addressing HIV as a chronic disease, recognizing chronic disease dimensions of co-morbidities such as substance use, major psychiatric disorders and chronic or recurring infectious diseases (e.g., HCV, HBV, HPV, TB).
• Examine the role of drugs of abuse on mother-to-child transmission of HIV in the presence of highly active antiretroviral therapy (HAART)

Cross-Cutting Issues

In addition to the above areas of research on sex/gender differences and issues unique to women, several research considerations and topic areas apply to many areas of research. They include, but are not limited to, the following:

• Research that addresses and compares stages of the life cycle, from preconception, gestation, infancy, childhood, adolescence, adulthood, to late adulthood.
• Research that examines the role of race, ethnicity, culture, and SES.
• Research that examines health disparity issues in drug abuse and associated infectious diseases.
• Research on hidden and underserved populations, e.g., lesbians, transgender individuals, incarcerated, homeless, victims of violence, sex workers, migrant workers, school dropouts, truants, runaways, street youth, and latchkey children.
• Research that addresses transgendered populations with special attention to improving methods for sampling those populations and to their elevated risk for drug use, and for HIV exposure and transmission.
• Research on all drugs of abuse, including the nonmedical use of prescription drugs, over-the-counter drugs with abuse potential, nicotine, club drugs, and polydrug use.
• Use of a wide range of methodological approaches including longitudinal studies, secondary data analyses, descriptive and ethnographic studies, use of and development of novel measurement tools, and interdisciplinary approaches.
• Research that addresses gender-specific recruitment and retention issues.

Drug Abuse in Pregnancy and the Post-Partum and Mental Health Comorbidity

See PA-09-174 Women's Mental Health in Pregnancy and the Postpartum Period (R01) for additional description of NIDA’s interest in basic and clinical research and prevention and treatment interventions on this topic.

Secondary Data Analyses

Under this announcement, investigators may request funds to perform secondary data analyses of either their own data sets or other data sets that are publicly available. For example, NIDA's Clinical Trials Network Data Share website (http://www.ctndatashare.org) currently includes HIPAA-de-identified raw data from 23 studies completed by NIDA's Clinical Trials Network, 20 of which are randomized multi-site clinical trials. No approval is needed to download the data.

Revision (formerly competing supplement) Applications

NIDA welcomes applications that request a revision (formerly competitive supplement) to their active NIDA grant in order to pursue research on women and sex/gender differences that is relevant to the parent grant, but which reflects a significant expansion of the scope or research protocol of the parent grant. The duration of the supplement may not exceed the end date of the active parent grant. For other requirements and instructions, see https://grants.nih.gov/grants/funding/424/index.htm .

Alcohol-related problems including alcohol use disorders (abuse and dependence) represent a significant public health problem that is associated with considerable harm to the individual and society. Epidemiological surveys indicate that, among women, alcohol dependence has not declined, while alcohol abuse has increased. Despite the fact that alcohol use is more prevalent among men than women, the genetic and biological mechanisms for these differences in drinking patterns are not fully known. For example, women become intoxicated faster than men, achieve higher concentrations of alcohol in the blood after drinking equivalent amounts of alcohol, and appear to eliminate alcohol from the blood faster than men. These findings may be due to various physiological processes and fluctuations in gonadal hormonal levels that affect the rate of alcohol metabolism making women more susceptible to alcohols effects. Consequently, women’s health may be more adversely affected than men’s with the experience of adverse effects that include but are not limited to intentional or unintentional injuries (e.g., suicide, traffic-related injuries, falls), acute or chronic health effects (e.g., fetal alcohol syndrome, increased risk for certain cancers, liver disease, brain damage, alcohol-induced organ damage), social and/or interpersonal problems (e.g., sexual assault, physical abuse, violence), and mental health problems (e.g., mood and anxiety disorders).

Research findings suggest that there are certain high risk groups (e.g., racial/ethnic) and vulnerable populations (e.g., underage and younger drinkers) for which more research is needed that examines etiological issues, complexities of drinking pattern trajectories, genetic risks, neurobehavioral processes, environmental influences, other drug and/or psychiatric comorbidity, strategies for early identification, and the development of effective prevention interventions.

NIAAA is interested in the research areas in this FOA exemplified in I. Etiology and Mechanisms, II. Consequences and Impact, III. Prevention and Prevention Services, and V. HIV/AIDS and Related Infectious Diseases as they relate specifically to alcohol consumption. The research areas of particular interest to NIAAA include, but are not limited to, the following:

I. EPIDEMIOLOGY AND PREVENTION:

• Studies that evaluate sex differences in vulnerability to alcohol initiation, lifespan drinking trajectories, transitions over the life course, intentional/unintentional alcohol-related injuries, including poisonings/overdose involving alcohol alone or in combination with other drugs, and risk/protective factors associated with initiation, progression, and maintenance of alcohol use.
• Studies that investigate sex differences in risk and protective factors for alcohol-related violence and victimization, and determine how these factors vary and/or interact in different sub-populations (e.g., age, ethnicity, child or adult victims, etc.) and/or are moderated by factors such as family history, education, comorbid illicit drug use and/or psychiatric disorders, and socioeconomic status.
• tudies that clarify our understanding of sex differences in how alcohol use interacts with academic trajectories and social achievement, impulsivity, negative affect, interpersonal relations, and risk for comorbid illicit drug use and/or psychiatric comorbidity.
• Studies that examine the relation between alcohol abuse and dependence and chronic diseases, sexual dysfunction and reproductive health, prenatal exposure, illicit drug use, onset and/or exacerbation of psychiatric disorders, acquisition and transmission of infectious diseases (e.g., HIV, HCV, TB, STDs, and others) in various sub-populations.
• Studies that develop gender-based screening instruments for early identification of risk for alcohol use disorders, particularly for use with adolescents in multiple settings (e.g., health care, school, etc.).
• Studies that test the effectiveness and cost effectiveness of developmentally-appropriate gender-based individual, family, and/or community-based prevention interventions that reduce the risk for the development of alcohol use disorders, particularly for adolescents and young adults.
• Studies that explore gender differences in being screened for risking drinking and being offered advice about related harms, and that explore differences in seeking professional help for alcohol use disorders.
• Studies that evaluate the effectiveness of prevention programs to reduce drinking during pregnancy and risk of fetal alcohol spectrum disorders (FASD)

II. NEUROSCIENCE:

• Basic behavioral, neurobiological, physiological/hormonal, and genetic mechanisms underlying sex differences in patterns of alcohol abuse and dependence.
• Human and animal studies examining the sex differences in consequences of chronic alcohol use on the brain and cognition, the mechanisms underlying these differences, and particularly the consequences that are unique to women.
• Documenting male/female variations (patterns) of voluntary alcohol intake in animal models, including comparisons of males and females in a variety of drinking paradigms
• Establishing the influence of hormones (centrally and/or peripherally synthesized) on male/female differences in patterns of alcohol intake and response to alcohol intake.

III. PUBERTAL AND HORMONAL PROCESSES:

NIAAA has a special interest in sex/gender differences in drinking patterns that become apparent during puberty, and the mechanisms underlying these differences. Specifically, we are interested in research that will increase our understanding of 1) the degree to which hormonal changes at puberty interact with neurodevelopmental processes to promote sex effects in alcohol use and misuse, and 2) the effects of adolescent alcohol exposure on these interactive processes. Research areas of include the following:

• Mechanisms by which changes in gonadal steroids (estrogen, progesterone, androgens) and neuroactive steroids (e.g., allopregnanolone, pregnenolone, DHEA) during adolescence modulate neurotransmitters systems (e.g., 5-HT, GABA, DA, opioids) to promote sex differences in alcohol drinking.
• Age and sex- related changes in stress responsiveness to alcohol, and the neurobiological and hormonal mechanisms of these changes.
• How pubertal changes in gonadal, neuroactive steroids, and stress hormones interact within structures in the brain reward circuit to promote sex differences in alcohol use and misuse that occur during this time.
• The effects of hormonal presence or absence during adolescence (e.g., gonadectomy, hormone replacement studies) on the development of sex differences in drinking behavior and dependence liability that emerges in late puberty.
• Whether adolescence represents a period of unique sensitivity to alcohol in modulating development of alcohol abuse through its effects on hormonal regulation of sex-specific changes in neuronal circuits (including synapse formation and pruning, glial development), particularly in reward and emotional circuits.

Secondary Data Analyses

Under this announcement, investigators may request funds to perform secondary data analyses of either their own data sets or other data sets that are publicly available.

Revision (formerly competing supplement) Applications

NIAAA welcomes applications that request a revision (formerly competitive supplement) to their active NIAAA grant in order to pursue research on women and sex/gender differences that is relevant to the parent grant, but which reflects a significant expansion of the scope or research protocol of the parent grant. The duration of the supplement may not exceed the end date of the active parent grant. For other requirements and instructions, see https://grants.nih.gov/grants/funding/424/index.htm .

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see https://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding- for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (https://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	The combined budget for direct costs for the two year project period may not exceed $100,000. No more than $50,000 in direct costs may be requested in any single year.
Award Project Period	The maximum project period is 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review (CSR) in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
TTY: 301-451-5936
Email: [email protected]

Samia Dawud Noursi, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-5622
Email: [email protected]

Deidra Roach, MD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-5820
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Ms. Heidi Young
National Institution on Drug Abuse (NIDA)
Telephone: 703-243-8267
Email: [email protected]

Ms. Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301- 443-4704
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.